Erin Flynn
Greenwood Village,Colorado
Summary
Seasoned Regulatory Affairs consultant, offering over 10 years of related experience, and dedication to client programs to achieve remarkable results. Organized and dependable candidate, successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
11
11
years of professional experience
Work History
Regulatory Strategist
Veristat LLC
11.2020 - 01.2024
- Provide clinical, nonclinical, and CMC regulatory advice to small molecule, biologic, and biosimilar programs in all phases of development
- Serve as Regulatory Lead on client programs, overseeing cross-functional execution of regulatory strategies
- Oversee the writing, submission, and maintenance of multiple client FDA regulatory filings, including IND and orphan drug applications
- Serve as client US Agent/Authorized Regulatory Representative, leading FDA communications and handling all FDA information requests
- Provide FDA meeting support, to include writing of meeting requests and briefing documents, design of meeting questions, and pre-meeting preparations
- Prepare department-wide trainings on the latest regulatory developments
- Mentor incoming regulatory strategists, bringing them up to speed on department policies and providing client guidance
Associate Director of Regulatory Affairs
WCCT Global
12.2016 - 11.2020
- Oversee submission, filing, and maintenance of all client and internal FDA regulatory documents
- Serve as US Agent and Authorized Regulatory Representative on client filings with FDA
- Responsible for writing, review, and project management of IND submissions on expedient timelines
- Responsible for writing, review, and strategic guidance on alternative pathways including orphan drug designations and 505(b)(2) applications
- Prepare and submit IND Safety Reports, Annual Reports, protocol amendments, and other IND amendments
- Pre-IND meeting support, including request submission, briefing book preparation, logistics, on-site planning, and facilitation onsite at FDA for face-to-face meetings
- Develop internal Standard Operating Procedures and policies to ensure regulatory compliance
Regulatory Analyst
Aegis Creative
12.2015 - 11.2016
- Lead Regulatory Intelligence Client programs
- Prepare summaries of drug approvals, summarizing clinical trial efficacy and safety results, significant regulatory events, and drug mechanisms of action
- Prepare summaries of FDA review documents associated with significant drug approvals
- Monitor FDA and Federal Register publications, identifying significant industry developments and informing clients
- Monitor advisory committee meetings of interest and prepare debriefs
- Prepare an annual summary of FDA activities, to include the approval of new molecular entities, FDA-reported trends, and innovation in regulation
Scientific Consultant
CBR International Corp.
05.2015 - 12.2015
- Responsibilities of Quality Associate III, and
- Responsible for the writing, review, and project management of an IND
- Serve as a mentor for training and oversight of new Project Associates, reviewing client
communications and client deliverables against company standards - Lead client programs providing strategic and regulatory advice on quality, regulatory, clinical, and scientific affairs
- Prepared and presented company-wide cGMP training
- Develop internal Quality Systems for documentation and oversight of client operations
Quality Associate III
CBR International Corp
07.2014 - 05.2015
- Lead client programs providing strategic and regulatory advice on quality matters
- Perform Quality audits of manufacturing facilities to assess cGMP compliance with FDA and ICH regulations and guidance
- Prepare audit reports and review audit outcomes
- Analyze adequacy of deviation reports based on data collected, including detailed root cause analysis and trend analysis, and perform investigations
- Perform mock-PAIs in support of upcoming FDA audits
- Review cGMP compliant technical documents, including: Standard Operating Procedures (SOPs), General technical reports summarizing historical development work, Master Batch Records
Technical and Quality Associate
CBR International Corp
08.2013 - 07.2014
- Write, edit, and review technical documents in support of client programs to include Nonclinical study reports, IND CTD sections, and method validation protocols and reports
- Review and QC CSR’s prior to regulatory submission
- Prepare materials and background information in advance of meetings
- Provide support to consultants and programs as a Project Associate
- Prepare and issue audit reports and review audit outcomes
- Assist submissions team for final review, preparation, and transmission of regulatory documents to FDA.
Manufacturing Technician
Agilent Technologies
01.2013 - 08.2013
- Follow cGMP and GDP industry standards
- Prepare solutions, standards, and buffers to support GMP API processing
- Clean rooms, buffer tanks, and critical processing equipment including synthesizers, HPLCs, concentrators, and lyophilizers
- Support the chemist staff by preparing and collecting raw materials, organizing, and stocking
- Resolve internal quality assurance observations in the production suites
- Read and review SOPs
- Manage time efficiently to perform multiple operations simultaneously and properly.
Education
Bachelor of Science - Biochemistry and Molecular, Cellular, and Developmental Biology (MCDB)
University of Colorado At Boulder
05.2012
Skills
- Client relationship management
- Data analysis
- Multiple document management systems, including Master Control and Veeva
- Advanced proficiency with Microsoft Office Suite and Adobe
Volunteer Experience
Relay For Life, Boulder Committee, 11/2013, 07/2014, Mission Delivery Chair and Luminaria Co-Chair, Served as the Mission Delivery Chair and Luminaria Co-Chair on the Volunteer Committee for the 2014 Boulder Relay for Life, Helped coordinate and organize Relay for Life events, fundraising, and luminaria ceremony, Served as a Team Captain raising funds for Relay for Life
Timeline
Regulatory Strategist
Veristat LLC
11.2020 - 01.2024
Associate Director of Regulatory Affairs
WCCT Global
12.2016 - 11.2020
Regulatory Analyst
Aegis Creative
12.2015 - 11.2016
Scientific Consultant
CBR International Corp.
05.2015 - 12.2015
Quality Associate III
CBR International Corp
07.2014 - 05.2015
Technical and Quality Associate
CBR International Corp
08.2013 - 07.2014
Manufacturing Technician
Agilent Technologies
01.2013 - 08.2013
Bachelor of Science - Biochemistry and Molecular, Cellular, and Developmental Biology (MCDB)
University of Colorado At Boulder
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